NCT06049953|RecruitingFDA Drug
Maternal And Infant Antipsychotic Study
MAIA
Developmental Effects of Antenatal Exposure to Antipsychotics
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MAIA
Developmental Effects of Antenatal Exposure to Antipsychotics
Sponsor study identifier
Secondary identifiers
observational
74
1 country
1
Study Start
September 29, 2023
Actual (reported)Primary Completion
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this observational study is to learn about maternal psychiatric course and infant development in pregnant individuals with severe mental illness, comparing those treated with antipsychotics to those treated with other medications or without medication. The main questions it aims to answer are:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 11, 2023
Actual (reported)September 22, 2023
Actual (reported)September 29, 2023
Actual (reported)January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Mini-International Neuropsychiatric Interview
In the DSM-5 Mini-International Neuropsychiatric Interview (M.I.N.I.) researchers will conduct modules for major depressive episode, (hypo)manic episode, and psychotic disorders. A clinical structured interview with very precise questions about psychological problems will require a 'yes' or 'no' answer. The M.I.N.I. is divided into modules identified by letters, each corresponding to a diagnostic category. At the beginning of each diagnostic module (except for psychotic disorders module), screening questions(s) corresponding to the main criteria of the disorder are presented in a gray box. At the end of each module, diagnostic box(es) permit the clinician to indicate whether diagnostic criteria are met.
through study completion, an average of 6 months postpartum
Finnegan Neonatal Abstinence Scoring System
Symptoms of poor neonatal adaptation, as assessed by Finnegan scale at 24 hours of life. Finnegan Neonatal Abstinence Scoring System (NAS) is an observer-rated scale documenting signs of neonatal adaptation. The individual NAS symptoms are weighted (numerically scoring 1-5) depending on the symptom, and the severity of the symptom expressed. The total score ranges from 0 to 43. Infants scoring an 8 or greater are recommended to receive pharmacologic therapy.
24 hours postnatal
Maternal weight gain
through delivery, approximately 40 weeks post conception
Oral glucose tolerance test score
at 24 weeks
Fetal body size
at 20 weeks
Fetal weight
at 20 weeks
Fetal head circumference
at 20 weeks
Pregnant women with severe mental illness (diagnosis of bipolar disorder, primary psychotic disorder, or any history of psychiatric hospitalization) who are treated with any of the following medications during pregnancy: Quetiapine, olanzapine, risperidone, aripiprazole, ziprasidone, lurasidone, haloperidol, or any other medication in the first- or second-generation antipsychotic class. All orally administered, with dosages titrated to clinical effect by the participant's primary psychiatrist.
Pregnant women with severe mental illness (diagnosis of bipolar disorder, primary psychotic disorder, or any history of psychiatric hospitalization) who are treated with any psychotropic medications during pregnancy other than those listed.
Pregnant women with severe mental illness (diagnosis of bipolar disorder, primary psychotic disorder, or any history of psychiatric hospitalization) who are not treated with any psychotropic medications during pregnancy.
Antipsychotic medications are widely prescribed for severe mental illness such as affective and non-affective psychosis, mood stabilization, and augmentation of unipolar depression.
Psychotropic medications are typically prescribed to manage symptoms of anxiety, depression, psychological distress, and/or insomnia.
Pregnant women with severe mental illness as defined in Eligibility Criteria
Icahn School of Medicine at Mount Sinai
New York, New York, 10029, United States
Paired whole blood and plasma samples obtained from the mother and from the umbilical cord at delivery will be stored.
Thalia Robakis, MD, PhD
Icahn School of Medicine at Mount Sinai
First Submitted
September 11, 2023
First Posted
September 22, 2023
Study Start
September 29, 2023
Actual (reported)Primary Completion
January 1, 2028
EstimatedDevelopment of a Lifestyle Physical Activity Intervention to Reduce Risk for Perinatal Cannabis Use - RCT
Ratio of auditory evoked potentials as measured by EEG
Electrical activity of brain cells in response to a sound stimulus, measured noninvasively on the outside of the scalp by electroencephalography
6 months postnatal
Non-psychotropic medications
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
January 1, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
June 22, 2026
Record last verified: 2026-06
Data will be stored and shared in accordance with HIPAA and GDPR law. Deidentified data will be shared between the two sites for the purpose of analysis of study outcomes. For this purpose: * dataset will be deidentified * datasets will be limited * data will be aggregated * no directly traceable data will be shared * data keys will never be shared between sites * data will be encrypted The process will be legally supported by Data transfer Agreements. Deidentified US data will be stored at the NICHD Data and Specimen Hub (DASH). Deidentified Dutch data will be stored at the electronic archives at the Erasmus MC. Repositories will be accessible for researchers of the MAIA study with the proper access rights, only
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Source: ClinicalTrials.gov.
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